Siemens Healthcare Diagnostics, Inc.: Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
- Reason / hazard
- The potential for falsely elevated results.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., Uganda, United Kingdom , Uruguay, Uzbekistan, Vatikancity, Vietnam, Zaire.
- Recall initiated
- 2026-08-17
- Code info
- Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots;
- Product quantity
- 42940 units (3938 US, 39002 OUS)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Tarrytown
- State
- NY
- Country
- United States
- Event id
- 99726
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